02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
23:41 , May 16, 2018 |  BC Extra  |  Company News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
17:16 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs US WorldMeds' opioid withdrawal candidate

US WorldMeds LLC (Louisville, Ky.) said FDA's Psychopharmacologic Drugs Advisory Committee voted 11-1 to recommend approval of an NDA for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation...
18:37 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

FDA panel to review US WorldMeds' opioid withdrawal candidate

FDA said its Psychopharmacologic Drugs Advisory Committee will meet on March 27 to discuss an NDA from US WorldMeds LLC (Lousiville, Ky.) for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion...
21:46 , Dec 1, 2017 |  BC Week In Review  |  Company News

FDA reviewing US WorldMeds’ opioid withdrawal candidate

FDA accepted and granted Priority Review to an NDA for lofexidine from US WorldMeds LLC (Louisville, Ky.) to mitigate symptoms associated with opioid withdrawal. Its PDUFA date is in 2Q18. Lofexidine is an agonist of...
20:37 , Nov 21, 2017 |  BC Extra  |  Company News

FDA reviewing US WorldMeds’ opioid withdrawal candidate

FDA accepted and granted Priority Review to an NDA for lofexidine from US WorldMeds LLC (Louisville, Ky.) to mitigate symptoms associated with opioid withdrawal. Its PDUFA date is in 2Q18. Lofexidine is an agonist of...
07:00 , Jul 28, 2014 |  BC Week In Review  |  Clinical News

APL-130277: Phase II started

Cynapsus began the open-label, U.S. Phase II CTH-105 trial to evaluate titrated doses of APL-130227 in 16 apomorphine-naive PD patients who experience >=1 daily “off” episode with a total duration of “off” in any 24-hour...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Clinical News

Cynapsus preclinical data

A hamster irritation study showed that thrice-daily sublingual APL-130277 for 28 days led to no irritation as determined macroscopically (by clinician observation of the oral cavity) or microscopically. Cynapsus said the study is required by...
07:00 , Apr 21, 2014 |  BC Week In Review  |  Clinical News

APL-130277: Interim pilot trial data

Interim data from 9 healthy volunteers in the single-arm, placebo-controlled pilot CTH-104 trial showed that a single dose of 25 mg sublingual APL-130277 was well tolerated. Cynapsus said the 25 mg dose of APL-130277 did...
08:00 , Jan 20, 2014 |  BC Week In Review  |  Clinical News

APL-130277: Pilot trial data

Top-line data from the placebo-controlled, crossover pilot CTH103 trial in 29 healthy volunteers showed that sublingual APL-130277 was better tolerated than subcutaneous apomorphine. Patients received 10 or 15 mg APL-130277 and were crossed over to...